Proactive Treatment of Tacrolimus Ointment for Adult Facial Seborrheic Dermatitis

Seborrheic Dermatitis Clinical Trial

Official title:

Phase 4 Study of Proactive Treatment of Tacrolimus Ointment for Adult Facial Seborrheic Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01591070
• Other study ID #: PNUHDM
• Status: Completed
• Phase: Phase 4
• First received: April 25, 2012
• Last updated: August 7, 2012
• Start date: November 2010
• Est. completion date: May 2011

Study information

• Verified date: August 2012
• Source: Pusan National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether proactive use of 0.1% tacrolimus ointment once or twice weekly can keep adult facial SD in remission and reduce the incidence of exacerbation.

Description:

Seborrhoeic dermatitis (SD) is a common chronic papulosquamous dermatosis, affecting 2% to 10% of the adult population, mainly those between the ages of 20 and 50 years with a male bias. The affected skin appears erythematous and oedematous, covered with yellow-brown scales, and is often accompanied by pruritus. It typically affects areas containing sebaceous glands, particularly the scalp, ears, face, chest, and intertriginous areas. SD has a chronic course, and relapse is common. Therefore, therapy is directed toward reducing the symptoms or aggravating factors of SD, such as loosening and removal of scales and crusts, inhibition of yeast colonization, control of secondary infection, and reduction of erythema and pruritus. Standard topical treatments for SD include corticosteroids and anti-mycotic medications. However, the chronic use of topical corticosteroids particularly on the face could result in undesirable outcomes, such as telangiectasia, atrophy, striae, peri-oral dermatitis, or tachyphylaxis, and early relapse after discontinuation of treatment. SD relapse prevention strategies have not yet been established, so the investigators suspected that intermittent use of tacrolimus ointment can be effective in preventing SD relapse.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• at least 18 years of age with a diagnosis of facial seborrhoeic dermatitis

Exclusion Criteria:

• taking other systemic or topical treatments for facial seborrhoeic dermatitis within the previous 4 weeks

• a known allergy to the components of tacrolimus ointment

• malignant neoplasm; immunologic abnormality

• active infection

• other definitive cutaneous findings such as erythroderma, acne, and psoriasis

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Seborrheic
• Eczema
• Seborrheic Dermatitis

Intervention

Drug:
• Tacrolimus
0.1% tacrolimus once-weekly application for 10 weeks
• Tacrolimus
0.1% tacrolimus twice weekly application for 10 weeks

Locations

Country	Name	City	State
Korea, Republic of	Department of dermatology, Pusan National University Hospital	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical assessments of erythema, scaling, and pruritus	The clinical assessments of erythema, scaling, and pruritus will be evaluated by investigator using 4-point scale: 0 (absent), 1 (mild), 2 (moderate), or 3 (severe).; Maintenance of stabilised facial Seborroheic dermatitis will be considered those patients who showed significant improvement of clinical assessment in erythema, scaling, and pruritus compared with the baseline values.	12 weeks	No